FDA applicant

Summit Doppler Systems, Inc.

Golden, CO7 decisions2003–20111 recall

FDA records 7 decisions for Summit Doppler Systems, Inc. (Golden, CO) from 2003 to 2011: 7 510(k) clearances. Most are in product codes JAF (Monitor, Ultrasonic, Nonfetal) and KNG (Monitor, Ultrasonic, Fetal). Its devices cite 10 predicates, 5 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

How often FDA has decided Summit Doppler Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2007high 2 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2017

2007high 1 (2017) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Summit Doppler Systems, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Summit Doppler Systems, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Summit”

FDA records each applicant name separately; these may or may not be the same firm.

Summit Medical, Inc. 14 Summit World Trade Corp. 10 Summit Industries, Inc. 8 Summit Nuclear 6 Summit Technology, Inc. 5 Summit Glove, Inc. 5 Summit Medical Products, Inc. 4 Summit Optics, Inc. 2 Summit Spine 2 Summit Medventures 2 Summit Durable Medical Equipment, Inc. 1 Summit TO Sea 1

Summit Doppler Systems, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Summit”